Low-dose Dasatinib as First-line Treatment for Chronic Myeloid Leukemia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-01

Study Completion Date

2018-10-01

Brief Summary

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Our goal is to demonstrate that 50mg of dasatinib is as effective as the full dose to induce molecular response as first line therapy in CML.

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Detailed Description

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We will give 50mg of dasatinib daily since the diagnosis for up to 6 months, for the first 2-4 weeks we will evaluate hematic biometry to registry hematic response, at months 3 and 6 a BCR/ABL PCR will be taken to evaluate molecular response.

Conditions

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Chronic Myelogenous Leukemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm1 Low Dose Dasatinib

We will give 50mg of dasatinib orally daily for 6 months

Group Type EXPERIMENTAL

Dasatinib 50 MG

Intervention Type DRUG

50mg of dasatinib orally daily

Interventions

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Dasatinib 50 MG

50mg of dasatinib orally daily

Intervention Type DRUG

Other Intervention Names

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Sprycel

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of BCR-ABL positive CML in early chronic phase CML. Except for hydroxyurea, patients must have received no or minimal prior therapy, defined as \<2 weeks (14 days) of prior FDA approved TKI.
* ECOG performance of 0-2
* Adequate end organ function, defined as the following: total bilirubin \<1.5x ULN, SGPT \<2.5x ULN, creatinine \<1.5x ULN.
* Patients must sign an informed consent indicating they are aware of the investigational nature of this study.

Exclusion Criteria

* NYHA cardiac class 3-4 heart disease or previous pleural effusion.
* Pregnancy and lactation
* Patients with active, uncontrolled psychiatric disorders

Minimum Eligible Age

16 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No